Safety, Tolerability, and Pharmacokinetics of EQU-001 in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety Issues

In brief

This is a randomized, placebo-controlled, double-blinded single and multiple ascending dose (SAD and MAD) study of the safety, tolerability, and pharmacokinetics of EQU-001 in healthy volunteers.

Key facts

Study ID: NCT05004571
Run by: Equilibre Biopharmaceuticals B.V.
People needed: 81
Starts: 2021-07-06
Expected to finish: 2021-09-04
Last updated by the study team: 2023-02-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Age 18 to 65 years of age
Weight 60 kg to 90 kg
Willing and able to
communicate in English or Spanish
provide written informed consent to take part in the study
be available for all visits and able and willing to comply with all study procedural requirements
In general good health in the opinion of the investigator as defined by:
The absence of clinically significant illness or surgery within 4 weeks of dosing. Participants vomiting within 24 hours before the first study drug administration will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Investigator or designee.
The absence of clinically significant neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease including uncontrolled diabetes.
Agree not to participate in other concurrent interventional and/or drug trials
Agree not to use nicotine containing products
Agree not to eat grapefruit, drink grapefruit juice or take St. John's wort for 5 days prior to study drug dosing and throughout the study.
If you or your heterosexual partner is pre-menopausal, you must agree to use an effective method of contraception and to continue use of an effective method for the duration of study participation and 2 weeks after. For this study, a clinical history of amenorrhea for ≥1 year without a separate identifiable cause and a medical history consistent with menopause meets criteria for post-menopausal. Acceptable methods are:
condom use together with an additional barrier method plus spermicide, hormonal methods, or an IUD
sterilization of participant or partner
heterosexual abstinence

You may not qualify if…

Pregnant or lactating
History of hypersensitivity to the EQU-001 API
History of EQU-001 API use within the previous 2 weeks
History of ocular conditions that interfere with pupillometry including inability to focus on an object 3 meters in front of them, current eye disorder under the care of an ophthalmologist, or pupil not readily distinguishable from the iris
History of excessive caffeine use (>8 cups of coffee or caffeine-containing energy drinks per day)
History of smoking or vaping within the past 3 months
History of substance abuse within 6 months (with the exception of medically indicated marijuana), including alcohol
Use of concomitant prescription medications within 5 days of the study drug dose
Use of an investigational drug or device or participation in an investigational study within 30 days prior to enrollment
Donation of blood within the previous 4 weeks
Has any of the following laboratory abnormalities at screening or baseline:
Breathalyzer result ≥ 0.1
Positive COVID test
Positive urine drug screen
Positive urine cotinine screen
Total bilirubin or higher ≥ 1.5 x the site laboratory ULN
ALT or ALT ≥ 2 x the site laboratory ULN
HbA1c ≥ 6.5%
Positive hCG (female pre-menopausal participants)
Received a COVID-19 vaccine within 7 days of the baseline visit
Any reason which, in the opinion of the PI, would prevent the subject from participating in the study

Where it is running

Clinical Pharmacology of Miami — Hialeah, Florida, United States

Full record on ClinicalTrials.gov

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